Manidipine was equivalent to amlodipine in reducing sitting systolic (15.2 vs 17.0 mm Hg) and diastolic (11.3 vs 12.3 mm Hg) blood pressure after 8 weeks, with significantly less ankle edema.
RCT (n=481)
Double-blind
randomly assigned
Sí
Does manidipine reduce blood pressure equivalently to amlodipine while improving tolerability and quality of life in patients with mild-to-moderate essential hypertension?
Long-term treatment with manidipine is as effective as amlodipine for blood pressure reduction but offers a better tolerability profile with less ankle edema and improved quality of life.
Tasa de eventos absoluta: 15.2% vs 17%
This double-blind, multicenter trial compared antihypertensive efficacy, tolerability, and impact on quality of life of manidipine and amlodipine in patients with mild-to-moderate essential hypertension. Patients were randomly assigned to 48 weeks of once-daily manidipine, 10-20 mg, or amlodipine, 5-10 mg. Patients who did not respond to treatment after 12 weeks were also given enalapril, 10-20 mg, for the study's duration. The main efficacy end point was equivalence in sitting systolic (SiSBP) and diastolic (SiDBP) blood pressure reduction between the two drugs after 8 weeks (per protocol analysis). An intention-to-treat (ITT) analysis was performed in all patients with at least one efficacy determination during treatment. Quality of life was assessed by the "Subjective Symptoms Assessment Profile" (SSA-P) and "General Well-being Schedule" (GWBS), after 12 weeks of treatment. SiSBP reduction after 8 weeks was equivalent for manidipine (15.2 mm Hg, n = 227) and amlodipine (17.0 mm Hg, n = 219). The corresponding figure for SiDBP was 11.3 mm Hg for manidipine and 12.3 mm Hg for amlodipine. In the larger ITT population SiDBP was similarly and significantly reduced by manidipine (from 102 +/- 5 to 88 +/- 9 mm Hg, n = 241) and amlodipine (from 101 +/- 5 to 87 +/- 8 mm Hg, n = 240). Similar results were observed for SiSBP and standing SBP and DBP. Neither drug changed sitting or standing heart rate compared with baseline. SSA-P scores improved with manidipine but not amlodipine. GWBS total and partial scores increased more with manidipine than with amlodipine. Safety profile favored manidipine, which was associated with significantly less ankle edema than was amlodipine. This study shows for the first time that long-term treatment with the long-acting calcium channel blocker manidipine is as effective as treatment with amlodipine, has a better tolerability profile, and induces greater improvement in quality of life than amlodipine.
Zanchetti et al. (Mon,) conducted a rct in mild-to-moderate essential hypertension (n=481). manidipine vs. amlodipine, 5-10 mg was evaluated on equivalence in sitting systolic (SiSBP) and diastolic (SiDBP) blood pressure reduction after 8 weeks. Manidipine was equivalent to amlodipine in reducing sitting systolic (15.2 vs 17.0 mm Hg) and diastolic (11.3 vs 12.3 mm Hg) blood pressure after 8 weeks, with significantly less ankle edema.
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